MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-26 for LX AQUA CALIBRATOR LEVEL 1 471288 manufactured by Beckman Coulter.
[98527473]
The customer replaced aqua calibrator level 1 l/n 72853811 with l/n 72935498 to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
[98527474]
The customer stated erroneously low na (sodium) patient results were generated on their unicel dxc 600 pro synchron system using aqua calibrator level lot 72853811. The customer stated the patient sample results were reported outside of the laboratory, however the results were amended/corrected with no change to patient treatment. A review of the customer provided data confirms the instrument generated 1 (one) erroneously low na patient result. A review of the na quality control (qc) data provided shows recoveries for level 2 were greater than 2sd low of the instrument control mean on the event date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050010-2018-00001 |
| MDR Report Key | 7222202 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-26 |
| Date of Report | 2018-01-02 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-01-02 |
| Device Manufacturer Date | 2017-05-17 |
| Date Added to Maude | 2018-01-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149313796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2470 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LX AQUA CALIBRATOR LEVEL 1 |
| Generic Name | LX AQUA CALIBRATOR LEVEL 1 |
| Product Code | JIX |
| Date Received | 2018-01-26 |
| Model Number | NA |
| Catalog Number | 471288 |
| Lot Number | 72853811 |
| Device Expiration Date | 2018-11-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2470 FARADAY AVE CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-26 |